Home Public Health New Drug Registration Process & Format of Documents for Import in Nepal

New Drug Registration Process & Format of Documents for Import in Nepal

by Public Health Update

Here is the checklist and format of documents required for new drug product registration, company registration, Import of Radioactive Substances and Import of Intra OcularLenses (IOL) in Nepal. This checklist has developed by the Department of Drug Administration (DDA).

Checklist for Company Registration

S.No.Document required
1Application by the importer for Company registration
2Application by the Company on its letterhead
3Letter of Authority to the importer
4Site Master File (as per PICS guidelines/WHO Guidelines)
5Notarized Copy of Up to date manufacturing license
6List of Products Intended to be registered in Nepal
7Letter of Warranty (Annex 3)
8Latest GMP internal audit report
9Photocopy of updated Wholesale registration
10Complete Dossier of one product intended to register
11WHO GMP certificate from concern regulatory authority
12Product registration and market authorization in SRA countries
13REMS (Risk Evaluation and Mitigation Strategy)including PV(Pharmacovigilance) and post Marketing Surveillance
14Approval letter from DDA on WHO GMP compliance (applicable for Non-SRA, Non UN prequalified products and company

Checklist for Product Registration

S. No.Document required
1An application in the form of Schedule 4 ‘C’(DDA document)
2An application in the form Schedule 6 (DDA document)
3Notarized Up-to-date manufacturing license issued
4Notarized Copy of Valid COPP as recommended by WHO
5Detail formulation including excipients, colour, flavour, etc
6In case of new drug combination / new molecule (document in the format designed by the Department).
7BA/BE if non pharmacopeial and modified release
8Product Specification
9Method of Analysis
10Monograph if pharmacopoeia
11Analytical Method Validation if non pharmacopoeia
12Samples of label and carton
13Sample of the product
14Analytical report from Company’s own laboratory
15Analytical report from independent laboratory (authorized)
16Real time stability (Zone IVb) of two batches for claimed shelf life
17Letter of Attorney (Annex 5)
18Price commitment for lower price than exporting company
19Comparative Price of at least 5 bands if available
20Company inspection report of DDA if audited

Checklist for Product Renewal

S. No.Document required
1 Application for renewal of 4 E and 7
2Original 4 E and 6
3Notarized COPP
4Notarized Valid Mfg. Lic
5Notarized Valid GMP
7Annual Product Review
8Stability information
9Declaration on ADR
10Price to importer, wholesaler, retailer and MRP
11Approval of variation made under the period
12Evidence of export to SRA in case of company registered under SRA export
13COA ( Certificate of analysis)

Documents Required for Import of Intra Ocular Lenses(IOL)
S. No.Document required
1Application by Importer
2Application by Company
3Manufacturing License
4Site Master File (SMF)
5ISO 9000 : 2000 Certificate
6EC Directives 93/42/EEC Annex II-CE Certification
7ISO 13485 : 2003 (Quality Management System of the Industry)
8ISO 11979 : 1999 (Standard of the Product)
9Quality Manual
10Sources of the Materials used in the Lens
11Authority Letter from the Manufacturer
12Test Report of the Lens
13Letter of Warranty
14Unit Price

Documents Required for Import of Radioactive Substances
S. No.Document required
1Application by Importer
2Industry Registration Certificate
3Company Registration Certificate.
4Approval letter from Government Agency for handling radioactive substances
5Material Safety Data Sheet
6Performa Invoice
7License from authorized Atomic Energy Regulatory Board
8Standard Operating Procedures for Transport, Handling, Storage and Disposal
9Radiation Protection Manual
10Consumption Report

Download Application form

Please contact dda for more information.

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